PHARMACEUTICAL DEVELOPMENT, VALIDATION, BIOEQUIVALENCE (IN-VITRO) AND COMPATIBILITY STUDY OF SOLID ORAL DOSAGE FORM (HARD CAPSULE) TETRACYCLINE

Abstract

This study reports the formulation development, analytical validation, and in-vitro comparative evaluation of generic Product Tetracycline 250mg hard gelatin capsules. The formulation was designed using Tetracycline as the active pharmaceutical ingredient, along with pharmacopeial excipients selected based on excipient compatibility studies conducted under accelerated conditions. The finished product met British Pharmacopoeia (B.P.) specifications for assay, dissolution, uniformity of dosage, and water content. Analytical method validation was performed using high-performance liquid chromatography (HPLC), and the method fulfilled all ICH and USP requirements for system suitability, specificity, accuracy, precision (repeatability and intermediate), robustness, and spiking recovery. Comparative dissolution studies were carried out in 0.1N HCl (pH 1.2), acetate buffer (pH 4.5), and phosphate buffer (pH 6.8) using USP Apparatus II. The test product demonstrated more than 85% drug release within 15 minutes in all media, and exhibited similarity factor (f2) values greater than 50 and difference factor (f1) values below 15 when compared with the reference product Resteclin® 250 mg. These results confirm the pharmaceutical equivalence of the test formulation and support its suitability for local production and regulatory approval.